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[pfract]

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie's Disease.

Alom M1, Sharma KL1, Toussi A1, Kohler T1, Trost L2.
Author information
Abstract
BACKGROUND:

Previous studies of penile traction therapy (PTT) devices have demonstrated limited/no efficacy when combined with intralesional therapies for Peyronie's disease (Peyronies Disease). Recently, randomized data have demonstrated the efficacy of a novel PTT device, RestoreX, developed in cooperation with the Mayo Clinic, in men with Peyronies Disease.
AIM:

To assess the safety and efficacy of treatment with the RestoreX device plus collagenase Clostridium histolyticum (CCH) compared with CCH alone and CCH with other PTT devices.
METHODS:

A prospective registry has been maintained of all men undergoing CCH injections for Peyronies Disease between March 2014 and January 2019. Assessments were performed at baseline, during each series, and after completion of treatment. Those completing therapy (8 injections or sooner if satisfied) were categorized into group 1 (CCH alone), group 2 (CCH plus any PTT device other than RestoreX), or group 3 (CCH plus RestoreX).
OUTCOMES:

Changes in penile length, curvature, and subjective perception and the occurrence of adverse events.
RESULTS:

Of 287 men with data on PTT use, 113 had completed therapy with all objective data available and compose the current cohort. Baseline demographic and pathophysiological variables were similar among the 3 groups except penile length and previous Peyronies Disease medications. Following treatment, group 3 demonstrated significantly greater improvements in curvature (mean, 20.3°/31% for group 1, 19.2°/30% for group 2, and 33.8°/49% for group 3), length (-0.7 cm/-4%, -0.4 cm/-2%, and +1.9 cm/+17%, respectively), and subjectively estimated curvature improvement (44%, 32%, and 63% respectively), despite shorter daily PTT use (0.9 vs 1.9 hours/day). Group 3 was more likely than the other groups to experience ≥20°, ≥20%, and ≥50% curvature improvements, ≥1 cm length gain, and ≥20% length improvement. All results were statistically significant for group 3 versus groups 1 and 2, but not between groups 1 and 2, even after controlling for baseline features and isolating a subset of ≥3 hours/day PTT use (group 2). Group 3 was 6.9 times more likely to achieve ≥20° curvature improvement, and 3.5 times more likely to achieve ≥50% curvature improvement, and 10.7 times more likely to experience ≥20% length improvement. Adverse events were similar among the 3 groups.
CLINICAL IMPLICATIONS:

Use of the RestoreX device enhances mean curvature outcomes by 71% and increases penile length in men with Peyronies Disease receiving CCH therapy.

STRENGTHS & LIMITATIONS:

Study strengths include a prospective registry, consistent assessments, the largest single-site series with complete posttreatment outcomes reported to date, the largest PTT series reported to date, and a true-to-life clinical design. Limitations include the nonrandomized methodology and single-site setting.
CONCLUSION:

The combination of RestoreX and CCH is associated with significantly greater curvature and length improvements compared with CCH alone or CCH with other PTT devices. Alom M, Sharma KL, Toussi A, et al. Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie's Disease. J Sex Med 2019;XX:XXX-XXX.

Very encouraging news for all those thinking about using the device and combining it with xiaflex. A must read!

[treeza1]

Do we know if they were in the acute or chronic phase?

[pfract]

Interesting question. I don't know. Maybe the full study mentions that particular thing?

[Throwaway23123]

Guys note that sponsor of this study was Mayo Clinic - founder of the device.

[Bubba dawg]

Guys note that sponsor of this study was Mayo Clinic - founder of the device.

OOps!
Your dick is so sore during treatment, can't imagine putting it in a stretcher

[pfract]

@Bubba I am  surprised you were not happy with the post!

[TonySa]

Mayo Clinic developed the device but makes no money from the sale, so I don’t really see any conflict of interest.  Great study, it’s so encouraging a major medical researcher is focusing on peyronies.

[pfract]

I could not agree more with you Tony, or being excited about the device. Not only there is a greater deal of attention on this condition, now there is a proper device with one of the best and biggest studies on the effects of traction and the device itself. The study even appeared on clinicaltrials.gov.

Hopefully the folks on this board using it will share their experiences more

[TonySa]

If anyone purchase the article, please let us know anything else you learn from it.  https://www.jsm.jsexmed.org/article/S1743-6095(19)30119-5/fulltext

[Bubba dawg]

I am for anything that would help improve Xiaflex success rate. Local Doctors don't seem to be recommending traction yet. Least not in Tonys case or mine. I may have to go back for more injections. Seems the a kink is redeveloping that makes it more difficult to have sex. This disease can come back I will ask the doctor about adding traction if and when I do get more treatment. May just be too much calcification to do any good. Let him check me out when I save up some more money. Hard to get my insurance company to cover the doctor injection fees. The exercises are similar to traction so I don't think it would hurt the situation. You just can't apply too much pressure. Got to be careful

[skunkworks]

If anyone purchase the article, please let us know anything else you learn from it.  https://www.jsm.jsexmed.org/article/S1743-6095(19)30119-5/fulltext

I emailed one of the authors asking for  the full text, sometimes works. I hate giving money to the paper peddlers.

[pfract]

Hey skunk. I can get you the full paper I think. Pm me for more details please.

[betterbend]

Guys note that sponsor of this study was Mayo Clinic - founder of the device.

True ... but those are the people that are going to do the research.  Doesnt mean that the results are bogus.  Look for the quality of the study.  This looks like a pretty well designed trial.  Hopefully someone comes out with similar results, but remember these studies are very expensive to conduct, so dont count on volumes of data coming out unless people can make money.  Perhaps the makers of Xiaflex will sponsor a study since it makes their treatment more effective and maybe becomes a standard of care. 

[pfract]

I second your post betterbend.

[skunkworks]

Trost sent me the full paper so I'll make it available as soon as I get a minute.

Edit. Turned out full text was freely available anyway, not sure how I missed that:

https://www.jsm.jsexmed.org/article/S1743-6095%2819%2930432-1/fulltext

One issue with it is that the restorex group was less than half the size of the other two groups, meaning outliers would have more effect on the average.

[pfract]

That was very nice of him still. So, I am curious actually skunkworks. How has your opinion on restorex changed after this new data?

[skunkworks]

My opinion has always been that we need more data, preferrably somewhere near the amount available for traditional traction devices. We're not there yet but it's certainly a good step in that direction. One of my worries with Restorex is with it having been tested on so few people (relatively), there is the chance that if the much higher tension is damaging for a small percentage of men, that might not have shown up in the studies yet...

I wish they'd managed to get more than 16 people on Restorex for the study, but I think we can all understand how that could be difficult. New device, rare disease.

[pfract]

Well, we do have the other one that had 117 participants on it with restorex? (I think)?

[skunkworks]

This is that study is it not? If not could you please link to the study you are talking about?

The above and the below are the only ones I know about:

https://www.ncbi.nlm.nih.gov/pubmed/30916626

So 55 + 16.

[betterbend]

I wish they'd managed to get more than 16 people on Restorex for the study, but I think we can all understand how that could be difficult. New device, rare disease.

That is a very good point.  Larger sample sizes are always desired in a study, bias and statistical anomalies can impact a small sample size like this...

[pfract]

Yes, that is the study I was mentioning. Is there people that where excluded in the study for not meeting a certain criteria and that's why you were saying its 55? Where have I read 117? :/ confused at the mo

[skunkworks]

Not sure where 117 comes from, that study was 110 people. But I now notice it was 3:1 PTT to control, not 1:1.

So 83 + 16.

[pfract]

I knew I wasn't crazy. lol

https://clinicaltrials.gov/ct2/show/NCT03389854

Study Design
Go to

Study Type :    Interventional  (Clinical Trial)
Actual Enrollment :    117 participants
Allocation:    Randomized
Intervention Model:    Factorial Assignment
Intervention Model Description:    Men will be randomized into one of four groups: no traction therapy, penile traction 30 minutes once daily, penile traction 30 minutes twice daily, and penile traction 30 minutes three times daily. This treatment will continue for 3 months, after which men will enter an open label phase for 3 months. Primary and secondary outcomes will be evaluated at the completion of the 3 month and 6 month time points. Additional AEs will be assessed at 9 months after study initiation.
Masking:    Double (Investigator, Outcomes Assessor)
Masking Description:    Objective outcomes including penile length and curvature will be masked for the investigator and outcome assessor by obtaining photographs of the penis in the lateral and dorsal planes. Curvatures will also be assessed by a clinician in the case where photographs are not able to be obtained or if the participant refuses photographs. These will be assessed without any knowledge as to which grouping the patient is located by two independent reviewers. If there are differences >5 degrees (curvature), or 0.5 cm (length), a 3rd individual will mediate the difference.
Primary Purpose:    Basic Science
Official Title:    Efficacy of Penile Traction Therapy Using a Novel Device: A Controlled, Single-blinded, Randomized Trial
Actual Study Start Date :    October 2, 2017
Estimated Primary Completion Date :    May 30, 2019
Estimated Study Completion Date :    August 30, 2019

[skunkworks]

Ok great stuff, hopefully it's released not long after the completion date.

If they're all new participants that'd add another 88-89 restorex users, awesome stuff.

[pfract]

@skunk

Just posted another study ongoing on restorex, on clinicaltrials.gov. this time related to its efficacy or not on prostate cancer patients. Estimated enrollment of 60 participants!

''Penile Length Maintenance Post-Prostatectomy'' - restorex study on going - Peyronies Society Forums

[kaz0034]

Mayo Clinic developed the device but makes no money from the sale, so I don’t really see any conflict of interest.  Great study, it’s so encouraging a major medical researcher is focusing on peyronies.

https://www.youtube.com/watch?v=Gre5WJYG6wc

reference timestamp 7:41.

The statement reads:

"The technology discussed in the preceding presentation was developed at Mayo Clinic by Dr. Landon Trost and licensed to PathRight Medical. Mayo Clinic and Dr. Landon Trost have inherent financial interests associated with its development and use. The viewpoints expressed represent those of Dr. Landon Trost and are not necessarily representative of Mayo Clinic or its affiliates.

I'm not debunking the potential efficacious nature of this device but there are in fact financial attachments and incentives to the device developer. This is by no means devious, part of the money received from sales goes directly to Dr. Trost because of his licensure. The development of products both help patients and ensure future research is ongoing.

[TonySa]

Good to know, I’m glad they published the info.

New study on restorex efficacy on treating peyronies disease!!!! 27/March 2019

Started by pfract Traction and Traction Devices for correcting Peyronies Disease

Xiaflex vs Xiaflex + any traction device not restorex vs Xiaflex+ restorex

Started by TonySa Traction and Traction Devices for correcting Peyronies Disease

Xiaflex alone vs Xiaflex + any traction not restorex vs Xiaflex + restorex

Started by TonySa Xiaflex - Trials and Treatment results